So-called vaginal rejuvenation processes have become much more popular throughout the years. However, the U.S. Food and Drug Administration has recently posted a vaginal rejuvenation FDA warning advising consumers against use of the energy-based devices.

According to the FDA’s announcement, the vaginal rejuvenation FDA warning pertains to energy-based devices and radiofrequency or laser devices that have received clearance by the FDA for “gynecologic tool indication.” These tools are meant to be used for the “destruction of abnormal or pre-cancerous cervical or vaginal tissue and condylomas (genital warts).”

Manufacturers of the devices have allegedly claimed that vaginal laser rejuvenation can treat a number of complications, from the vaginal wall to breast cancer treatment. However, the FDA has expressed serious concern in use of these devices for off-label treatments and notes that the agency has not cleared the device for use in those types of procedures.

According to the FDA Commissioner, “These products have serious risks and don’t have adequate evidence to support their use for these purposes.” He added, “We are deeply concerned women are being harmed.”

FDA Warning over Vaginal Rejuvenation Procedure

The FDA warning is to alert patients that there may be serious adverse side effects associated with use of energy-based devices when performing actions such as cosmetic vaginal procedures, non-surgical vaginal procedures, or in treating urinary incontinence, sexual function, and menopause.

The FDA states that “[t]he safety and effectiveness of energy-based devices for treatment of these conditions has not been established.” The agency notes that it has not cleared or approved the energy-based devices to perform any of the aforementioned procedures.

Several adverse side effects are being associated with the laser device that includes scarring, pain during sexual intercourse, vaginal burns, and recurring or chronic pain, the FDA states.

Warning Recommendations

Vaginal rejuvenation as defined by the FDA includes non-surgical procedures that treat vaginal symptoms such as:

• Vaginal laxity
• Vaginal atrophy, dryness, or itching
• Pain during urination
• Pain during sexual intercourse
• Decreased sexual sensation

The vaginal rejuvenation FDA warning recommends patients to:

• Be aware that procedures related to vaginal “rejuvenation” or cosmetic vaginal procedures has not been established.
• Discuss with your physician benefits and risks for all vaginal symptom treatment options.
• Understand that the FDA has yet to clear and approve energy-based medical devices for procedures related to vaginal “rejuvenation” or vaginal cosmetic procedures; and for the treatment of symptoms such as urinary incontinence, sexual function, and menopause.
• File a report through the FDA Safety Information and Adverse Event Reporting program or MedWatch for treatments related to vaginal “rejuvenation” if any complications have come up.

The Vaginal Rejuvenation FDA warning encourages physicians to:

• Discuss benefits and risks for all vaginal symptom treatment procedures with your patients.
• Be aware that performing vaginal “rejuvenation” or cosmetic vaginal procedures with energy-based devices has not been approved or its safety established.
• Report adverse side effects and complications to the FDA Safety Information and Adverse Event Reporting program and MedWatch.

FDA clearance has not been provided for energy-based medical devices for vaginal “rejuvenation” or vaginal cosmetic procedures. Attorneys are currently investigating the potential misrepresentations that are being made by the device manufacturers about treatments related to vaginal “rejuvenation.” If you or a loved one have been harmed or suffered severe adverse side effects, you may be eligible to join a class action lawsuit investigation.